Comparison of a Single Versus Double Perclose Technique for TAVR

NCT06173115 | Completed FDA Device

• 1 other identifier: SAHZJU CT022
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 25

Brief Summary

Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis. It has been proven to be a safe and effective option for patients who are at low, intermediate, and prohibitive risk for surgical valve replacement. One of the critical components of procedural success in a transfemoral approach is access site management, as vascular complications strongly correlate with adverse outcomes. When major vascular complications occur, there are higher rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as a significantly higher rate of 30-day and 1-year mortality. In recent years, a "preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site. This allows for arterial closure after dilation to sizing up to larger bore access sheaths that accommodate valve delivery systems. The sutures are subsequently harvested and tightened to close the large bore arteriotomy site at the end of the case. It has been demonstrated that the use of two Perclose devices, or double Perclose closure, is an effective closure technique with a low rate of vascular complications. A large number of TAVR centers have adopted this method for large-bore vascular closure. In the past, there have been few investigations comparing the utilization of a single Perclose device compared to a double Perclose technique. There are numerous theoretical advantages to the use of a single device, which include decreased procedural cost and procedural time. The investigation aimed to determine if there are clinical benefits as well using the single Perclose approach.

Conditions

Severe Aortic Stenosis

Keywords

transcatheter aortic valve replacement; vascular closure devices; randomized control trial

Outcome Measures

Primary Outcomes (1)

• The primary end point of the trial was the rate of access site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-3 criteria

  1. Aortic dissection or aortic rupture 2. Vascular (arterial or venous) injury (perforation, rupture, dissection, stenosis, ischaemia, arterial or venous thrombosis including pulmonary embolism, arteriovenous fistula, pseudoaneurysm, haematoma, retroperitoneal haematoma, infection) or compartment syndrome resulting in death, VARC type \>\_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment; 3. Distal embolization (non-cerebral) from a vascular source resulting in death, amputation, limb or visceral ischaemia, or irreversible endorgan damage; 4. Unplanned endovascular or surgical intervention resulting in death, VARC type \>\_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment; 5. Closure device failure c resulting in death, VARC type \>\_2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment

  The end point was assessed during index hospitalization

Secondary Outcomes (9)

• The rate of the primary end point at 30 days

  30 days

• Components of the primary end point in-hospital and at 30 days

  30 days

• In-hospital and 30-day major and minor vascular complications

  30 days

• Unplanned vascular surgery or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site

  30 days

• in-hospital and 30-day access site- or access-related minor, major, and disabling or life- threatening bleeding; need for blood transfusion for access site or access related bleeding or vascular complications

  30 days

Study Arms (2)

Double Perclose device

ACTIVE COMPARATOR

Double Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures

Device: Perclose Proglide system

Single Perclose device

EXPERIMENTAL

Single Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures

Device: Perclose Proglide system

Interventions

Perclose Proglide system DEVICE

"Preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site.

Double Perclose device; Single Perclose device

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead

Study Sites (25)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Location

Yulin First People's Hospital

Yulin, Guangxi, China

Location

Xiangya Hospital of Central South University

Changshacun, Henan, China

Location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Location

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

General Hospital of Northern Theater Command, PLA

Shenyang, Liaoning, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Location

Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, China

Location

Ningbo Medical Center Li Huili Hospital

Ningbo, Zhejiang, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Jianan Wang, PhD

  Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both the statistical analysis team and outcome assessors will remain blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: December 15, 2023
• Study Start: January 23, 2024
• Primary Completion: February 13, 2026
• Study Completion: March 19, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (25)